A Double Blinded Randomized Controlled Trial on Prophylactic Clipping to Prevent Post-polypectomy Bleeding After Colonoscopy in Direct Oral Anticoagulant Users
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The investigators hypothesize that prophylactic clipping after colonoscopic polypectomy can reduce risk of delayed PPB among DOAC users. The investigators also hypothesize that pre-endoscopy drug level can predict the risk of hemorrhagic complications after the procedure.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• They are active users of any DOAC
• They require elective colonoscopy for colorectal cancer screening, polyp surveillance, or investigation of symptoms such as anemia or past gastrointestinal bleeding
• Aged 18 years old or above;
• Written informed consent obtained.
Locations
Other Locations
Hong Kong Special Administrative Region
Prince of Wales Hospital
RECRUITING
Shatin
Contact Information
Primary
Louis Ho Shing Lau
louishslau@cuhk.edu.lhk
35052211
Time Frame
Start Date: 2021-12-15
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 584
Treatments
Experimental: Intervention group
In the intervention arm, one or more endoclips will be used to completely close the mucosal defect after polypectomy. Prophylactic clipping will be applied to all post-polypectomy sites. The total number of endoclips used will be recorded.
No_intervention: Control group
In the control arm, no endoclip will be applied to all post-polypectomy sites, with the exceptions of uncontrolled immediate PPB or pre-treatment in very large pedunculated polyps as specified above. The subjects with endoclips applied due to safety reasons will be included in the subsequent intention-to-treat analysis, but not the per-protocol analysis.
Related Therapeutic Areas
Sponsors
Leads: Chinese University of Hong Kong